FDA Extends Compliance Date For GUDID For Some Devices After Discovering Security Flaw

August 25, 2015

In 2013, FDA introduced a new set of regulations that would establish a unique device identification system for medical devices. They also announced the dates for implementation, which would be done according to device classification. This set of regulations, called the Global Unique Device Identification Database (GUDID) would ensure compliance with the Agency’s required labeling and data submissions (full guidance here).

Earlier this month, FDA took the system offline after discovering a security vulnerability. Because of this, the Agency has announced that the compliance date for “non-class III implantable, life-supporting and life-sustaining medical devices” will be extended from September 24, 2015 to October 24, 2015 (see full guidance here).

We can help ensure your device and company is compliant with FDA regulations! Our unique approach, which combines a deep scientific knowledge with extensive regulatory expertise, has helped a number of our clients ensure compliance and get through FDA successfully. For more information on how we can help you, please contact us.


November 19, 2015

FDA Holds Public Workshops to Discuss Regulatory Strategies for Next Generation Sequencing Diagnostics, Part 1

As we discussed in a previous FDA News article, the Agency is in the midst of developing “novel ways to optimize its regulation of Next Generation Sequencing (NGS) tests.” The Agency’s ultimate goal...

October 3, 2016

Self-Identification 101: Everything You Need to Know About FDA’s Self-Identification Requirements for Generic Drug Facilities, Sites, & Organizations

On Thursday, September 22, FDA issued a guidance document, entitled “Self-Identification of Generic Drug Facilities, Sites, and Organizations.” The document was published with the intention of...

November 3, 2015

Draft Guidance for Microbial Vectors Used for Gene Therapy Outlines FDA Safety Concerns

Issues for Sponsors with INDs and CMC concerns FDA recently released a draft guidance entitled “Recommendations for Microbial Vectors Used for Gene Therapy” as a supplemental guidance to “Guidance...